Pancrelipase (Pancreatic Enzyme Replacement Therapy) Dosing
For adults with exocrine pancreatic insufficiency, start with 500 units of lipase per kg per meal (approximately 40,000 units for an 80 kg patient) and 250 units of lipase per kg per snack (approximately 20,000 units for an 80 kg patient), titrating up as needed to control symptoms, with a maximum dose of 2,500 units/kg/meal or 10,000 units/kg/day. 1, 2
Initial Dosing by Age Group
Adults and Children ≥4 Years
- Starting dose: 500 units of lipase/kg/meal 1, 2
- For snacks: 250 units of lipase/kg (half the meal dose) 1, 2
- Example: For an 80 kg adult, this equals 40,000 units per meal and 20,000 units per snack 1
Adults with Chronic Pancreatitis or Pancreatectomy
- Starting dose: 500-1,000 units of lipase/kg/meal 2
- The American Gastroenterological Association recommends starting with at least 40,000 USP units of lipase per meal for a 70 kg adult, which is higher than the weight-based calculation alone 3
Children 12 Months to <4 Years
- Starting dose: 1,000 units of lipase/kg/meal 2
Infants Birth to 12 Months
- Dose: 3,000 units of lipase per 120 mL of formula or per breastfeeding 2
Maximum Dosing Limits
Critical safety thresholds that should not be exceeded without further investigation: 1, 2
- 2,500 units of lipase/kg/meal
- 10,000 units of lipase/kg/day
- 4,000 units of lipase/gram of fat ingested/day
Common pitfall: Exceeding 6,000 lipase units/kg/meal in pediatric patients <12 years has been associated with fibrosing colonopathy, particularly in cystic fibrosis patients 2
Dose Titration Strategy
Titrate upward based on clinical response if steatorrhea or gastrointestinal symptoms of maldigestion persist: 1, 2
- Increase gradually to the maximum safe limits listed above
- Higher dosages may be administered if documented to be effective by fecal fat measures or improvement in nutritional status 2
- Changes in dosage may require an adjustment period of several days 2
Administration Instructions
Timing is critical for efficacy: 1, 2
- Take enzymes during meals, not before or after 4, 2
- Distribute multiple capsules throughout the meal 3
- Swallow capsules whole with adequate liquid 2
For patients unable to swallow capsules: 2
- Open capsules and sprinkle entire contents on acidic soft food with pH ≤4.5 (applesauce, bananas, plain Greek yogurt)
- Consume immediately
- Do not crush or chew the enteric-coated contents 2
For infants: 2
- Sprinkle capsule contents on acidic soft food or directly into mouth immediately before feeding
- Do not mix directly into formula or breast milk bottle
- Visually inspect mouth to ensure no drug retention
Daily Dosing Schedule
Structure therapy around typical eating patterns: 1, 2
- Total daily dosage should reflect approximately 3 meals plus 2-3 snacks per day 1, 2
- Each snack receives approximately half the prescribed meal dose 1, 2
Monitoring Treatment Response
Assess the following parameters to determine efficacy: 1, 4
- Reduction in steatorrhea and gastrointestinal symptoms 1, 4
- Weight gain, muscle mass, and muscle function 4
- Improvement in fat-soluble vitamin levels (A, D, E, K) 4
- Annual assessment of micronutrient status and endocrine function (glucose, HbA1c) 1, 4
- Bone density scan every 1-2 years 1, 4
When Treatment Fails
If inadequate response despite appropriate dosing, consider: 1, 4
- Incorrect administration (timing, crushing capsules) 1
- Inadequate dosing 1
- Alternative diagnoses: celiac disease, small intestinal bacterial overgrowth, bile acid diarrhea, giardiasis 1, 4
- Need for proton pump inhibitor (for non-enteric coated preparations or to enhance efficacy) 3, 5
Product-Specific Considerations
All pancreatic enzyme replacement formulations are porcine-derived and equally effective at equivalent doses: 4
- Enteric-coated microsphere or minitablet formulations (≤2 mm diameter) are preferred 5
- Do not substitute between products without monitoring and dose adjustment 2
- Over-the-counter preparations should not be used as they are not standardized 3